Phase 2Active, not recruiting
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF
- Sponsor
- Avalyn Pharma Inc. (Industry)
- Enrolment
- 398 enrolled
- Conditions
- Pulmonary Fibrosis; Progressive Pulmonary Fibrosis; Pulmonary Fibrosis Secondary to Systemic Sclerosis; Pulmonary Fibrosis, Interstitial Lung Disease; Interstitial Lung Disease; Interstitial Lung Disease Due to Connective Tissue Disease (Disorder); Interstitial Lung Disease in Patients With Rheumatoid Arthritis; Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere; Hypersensitivity Pneumonitis; Interstitial Lung Disease With Systemic Sclerosis
- Interventions
- AP01; Placebo
- Ages
- adults, older adults
- Registry
- NCT06329401
Full record on ClinicalTrials.gov
From the registry
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
Primary outcomes
- To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
History
Primary completion expected
Last registry update
Started
Registered